MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-04-11 for DRAGONFLY IMAGING CATHETER 13751-02 NA manufactured by St Jude Medical.
[2591900]
The dragonfly catheter was not purged properly so when purged in the rca prior to oct imaging the captured air was introduced into the artery. The pt experienced chest pain and medications were administered. The pt was stable following the event.
Patient Sequence No: 1, Text Type: D, B5
[9858570]
It was reported that the event was not device related but occurred due to the air not being fully purged from the catheter prior to use, as instructed in the ifu. No product was returned. Review of the device history record confirmed all mfg processes were completed and the device was mfg in accordance with sjm specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2012-00003 |
| MDR Report Key | 2538934 |
| Report Source | 05,06,07 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-04-11 |
| Date of Event | 2012-03-08 |
| Date Mfgr Received | 2012-03-12 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2012-04-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN GRAVES |
| Manufacturer Street | ONE TECHNOLOGY PARK DR |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9786921408 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY IMAGING CATHETER |
| Generic Name | INTERVASCULAR IMAGING CATHETER |
| Product Code | NQQ |
| Date Received | 2012-04-11 |
| Model Number | 13751-02 |
| Catalog Number | NA |
| Lot Number | DF-11-751 |
| Device Expiration Date | 2013-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE MEDICAL |
| Manufacturer Address | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-11 |